Prefilled syringe trainer and resetting mechansim

ABSTRACT

Embodiments of a resettable injection training device are provided herein. The resettable injection training device includes a body and a retractable shield, extendable and retractable relative to the body of the device, in an embodiment. In another embodiment, the resettable injection training device may include an injection simulation member. The retractable shield may be lockable in an extended position, and may be unlocked to retract the shield for a subsequent use of the device in one non-limiting embodiment. In another non-limiting embodiment, a resetting component may be used to retract the shield to reset the device.

BACKGROUND

Injection devices have recently become increasingly popular for singledose or multi-dose, at home self-administration. These devices includeboth auto-injection devices and prefilled syringe devices, and are oftendesigned to accomplish two basic objectives: convenience of drugdelivery in an outpatient or at home setting, and/or automation of drugdelivery in an outpatient or at-home setting. These devices may bemechanically spring-loaded devices that advance a plunger or rubberstopper to transfer medication via hollow-bore needle to a patient'stissues. These devices lack the ability to regulate whether themedication is actually delivered to the patient or whether it isdelivered to a correct location. Most of these devices fail to integrateadvanced digital capabilities.

Injectable medications are required for a number of varying illnessesand diseases. A number of injectable medications require self-injectionby a patient. Self-injection of a medicament using a device having aneedle carries with it a certain stigma. Oftentimes patients are wearyof injecting themselves for fear or anxiety related to failing toreceive a complete dose of the medication, pain associated withinjecting oneself with the needle, accidentally sticking oneself withthe needle, and difficulties in adequately grasping the dosing mechanismto inject oneself, among other concerns. Auto-injection devices areroutinely used to provide a means for self-injecting certainmedications. The size and operation of these devices can often bedaunting to a patient, whether they are injecting themselves for thefirst or they have injected themselves before. These fears and anxietiesassociated with the currently available self-injection devices mayresult in the administration of an incomplete dose of a medicament,failure to administer any portion of the dose of a medicament, oraccidentally sticking oneself with the needle of the device, which insome instances could lead to unwanted transmission of diseases if theneedle is contaminated.

In some instances, after an injection is complete, the contaminatedneedle is retracted within the device or covered over by a needle guardor sheath and the entire device is disposed of. Therefore, mostinjection devices currently available are single use devices. Thesesingle use devices can be costly and economically wasteful.Alternatively, there are injection devices which require a user tore-cap a needle after the injection is complete such that the disposableneedle can be removed and discarded. These injection devices carry withthem the risk of unwanted sticking of oneself during re-capping of theneedle.

An additional concern exists with regard to injection devices is thatusers with little or no medical knowledge or experience are injectingthemselves or injecting others using these devices. Performing a medicaltreatment or test on oneself or others carries with it certain risks andoften creates a level of anxiety for the user performing the treatmentor test. It has proven beneficial in the medical field to practicevarious medical techniques including drug delivery, specifically whereit relates to injections and other invasive drug delivery means prior todelivering the medications to a patient in need, and particularly in thecase of self-administration of medicaments. Training devices are helpfulin reducing anxiety associated with self administering medicaltreatment, as well as increasing efficiency and accuracy in providingthe treatment to patients. Medical devices can be intimidating to use;the fear associated with giving oneself an injection, for example, canbe traumatic. This fear is increased in persons with little or noexperience in self-administration of medications. Consequently, devicesto assist in training individuals to inject themselves or otherwiseself-administer medication are beneficial in decreasing or preventingthe anxiety associated with medicament delivery.

Safe use and re-use of these devices requires resetting of the mechanismthat provides the movement of the device to initiate an injection andthe portion of the device that protects users from sticking themselves.Therefore, safely and efficiently resetting the device is paramount toan effective device for injection training.

SUMMARY

In one embodiment, a resettable injection training device including abody having an inner body and an outer body is provided herein. The bodycomprising a proximal end and a distal end, and a chamber defined withinthe body, the outer body having at least one first protrusion on aninner surface thereof. The device further including a plunger slidablewithin the inner body, a retractable shield associated with the body,the shield comprising a proximal end and a distal end, and beingretractable and extendable relative to the body, the shield comprisingat least one second protrusion on an outer surface thereof, wherein whenthe shield is in a retracted position, the at least one secondprotrusion abuts the at least one first protrusion, and wherein a firstthreshold force on the plunger causes the at least one second protrusionto traverse the at least one first protrusion to extend the shield; anda biasing member associated with the body, the biasing member comprisinga first end and a second end, the first end abutting a proximal end ofthe body, and the second end abutting the shield, wherein extension ofthe biasing member extends the shield, and retraction of the shieldbiases the biasing member, wherein the biasing member is configured toapply a biasing force to the shield less than the first threshold force,and wherein when the shield is in an extended position, a secondthreshold force applied to the distal end of the shield retracts theshield, wherein the second threshold force comprises a force of (x) N(Newtons); and wherein the resettable injection training deviceoptionally lacks (i) a needle, (ii) injection simulating component, or(iii) a medicament.

In another embodiment, a method including actuating an injectiontraining device having a body, the body comprising an inner body and anouter body, wherein the body includes a first protrusion on an innersurface thereof, the device including a plunger disposed there within,and a retractable shield being slidably movable relative to the device,the shield having a proximal end, a distal end and a second protrusionon an outer surface thereof, wherein in a retracted position, the secondprotrusion abuts the first protrusion, wherein actuation comprisesmoving the plunger in a first direction relative to the body such thatthe second protrusion traverses the first protrusion, and the shield isextended; and applying a force on the distal end of the shield until thesecond protrusion traverses the first protrusion such that the shield isretracted is provided herein.

In a further embodiment, a resettable injection training device,including a body having an inner body and an outer body, the body havinga proximal end and a distal end, and a chamber defined within the body,the outer body having at least one first protrusion on an inner surfacethereof is provided. The device further includes a plunger slidablewithin the body, a retractable shield associated with the body, theshield comprising a proximal end and a distal end, and being retractableand extendable relative to the body, the shield comprising at least onesecond protrusion on an outer surface thereof, wherein when the shieldis in a retracted position the at least one second protrusion abuts theat least one first protrusion, and wherein a first threshold force onthe plunger causes the at least one second protrusion to traverse the atleast one first protrusion to extend the shield, the shield comprisingat least one third protrusion proximal to the at least one secondprotrusion, wherein the at least one third protrusion abuts the at leastone first protrusion when the shield is extended; and a biasing memberassociated with the body, the biasing member comprising a first end anda second end, the first end abutting a proximal end of the body, and thesecond end abutting the proximal end of the shield, wherein extension ofthe biasing member extends the shield, and retraction of the shieldbiases the biasing member, wherein the biasing member is configured toapply a biasing force to the shield less than the first threshold force,and wherein when the shield is in an extended position, a secondthreshold force applied to the distal end of the shield retracts theshield, wherein the second threshold force comprises a force of (x) N.The device may further include one or more tab portions in the body,each tab portion comprising at least one fourth protrusion extendinginto the chamber, wherein the at least one fourth protrusion comprises alocking surface configured to abut the at least one third protrusion tolock the shield in an extended position, and an unlocking componentassociated with the body, wherein compression of the unlocking componentreleases the at least one fourth protrusion from the at least one thirdprotrusion, allowing movement of the at least one third protrusionrelative to the at least one fourth protrusion to retract the shield, inan embodiment.

In yet a further embodiment, a resettable injection training device isprovided including a body having an inner body and an outer body, thebody having a proximal end and a distal end, and a chamber definedwithin the body, the outer body having at least one first protrusion onan inner surface thereof. The device may further include a plungerslidable within the body, a retractable shield associated with the body,the shield comprising a proximal end and a distal end, and beingretractable and extendable relative to the body, the shield comprisingat least one second protrusion on an outer surface thereof, wherein whenthe shield is in a retracted position, the at least one secondprotrusion abuts the at least one first protrusion, and wherein a firstthreshold force on the plunger causes the at least one second protrusionto traverse the at least one first protrusion to extend the shield, anda biasing member associated with the body, the biasing member comprisinga first end and a second end, the first end abutting a proximal end ofthe body, and the second end abutting the shield, wherein extension ofthe biasing member extends the shield, and retraction of the shieldbiases the biasing member, wherein the biasing member is configured toapply a biasing force to the shield less than the first threshold force,and wherein when the shield is in an extended position, a secondthreshold force applied to the distal end of the shield retracts theshield, wherein the second threshold force comprises a force of lessthan (x) Newtons (N) in a non-limiting embodiment. The device mayfurther include a resetting component comprising a first end and asecond end and a channel disposed there between, the first endconfigured to associate with the distal end of the shield, and ashoulder member projecting inwardly toward the channel, and configuredto abut a distal end of the shield, wherein movement of the body towardthe resetting component retracts the shield and biases the biasingmember, such that the at least one second protrusion traverses the atleast one first protrusion to reset the injection training device, in anon-limiting embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description briefly stated above will be rendered byreference to specific embodiments thereof that are illustrated in theappended drawings. Understanding that these drawings depict only typicalembodiments and are not therefore to be considered to be limiting of itsscope, the embodiments will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 includes a cross sectional view of an embodiment of a resettableinjection training device prior to actuation.

FIG. 2 includes a cross sectional view of the embodiment of the deviceshown in FIG. 1 following manual actuation of the plunger;

FIG. 3 includes a cross sectional view of the embodiment of the deviceshown in FIGS. 1-2 following extension of a shield of the device;

FIG. 4 includes a cross sectional view of the embodiment of the deviceshown in FIGS. 1-3, further including a resetting component embodiment;

FIGS. 5A-B include a perspective view and an end view of an embodimentof a device shown in FIG. 1.

FIGS. 6A-6C includes a cross sectional view of another embodiment of aresettable injection training device.

FIG. 7 is a cross sectional view of another embodiment of a resettableinjection training device.

FIG. 8 is a cross sectional view of yet a further embodiment of aresettable injection training device.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles andoperation of the invention, reference will now be made to theembodiments illustrated in the drawings and specific language will beused to describe the same. It will nevertheless be understood that nolimitation of the scope of the invention is thereby intended, suchalterations and further modifications in the illustrated device, andsuch further applications of the principles of the invention asillustrated therein being contemplated as would normally occur to thoseskilled in the art to which the invention pertains.

It is to be noted that the terms “first,” “second,” and the like as usedherein do not denote any order, quantity, or importance, but rather areused to distinguish one element from another. The terms “a” and “an” donot denote a limitation of quantity, but rather denote the presence ofat least one of the referenced item. The modifier “about” used inconnection with a quantity is inclusive of the stated value and has themeaning dictated by the context. It is to be noted that all rangesdisclosed within this specification are inclusive and are independentlycombinable.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting. As used herein, thesingular forms “a,” “an,” and “the” are intended to include the pluralforms as well, unless the context clearly indicates otherwise theseterms do not denote a limitation of quantity, but rather denote thepresence of at least one of the referenced item. Furthermore, to theextent that the terms “including,” “includes,” “having,” “has,” “with,”or variants thereof are used in either the detailed description and/orthe claims, such terms are intended to be inclusive in a manner similarto the term “comprising.” Moreover, unless specifically stated, any useof the terms first, second, etc., does not denote any order, quantity orimportance, but rather the terms first, second, etc., are used todistinguish one element from another.

The term “protrusion” as used herein includes, but is not limited to, asurface, an element, or a portion of a surface or element that extendsout of the plane of the longitudinal axis of the element, for example. Aprotrusion may include a ridge, a bump, a lump, a knob, a projection, aprotuberance, a node, or a nodule, in non-limiting examples. Theprotrusion may be a portion of another element or may be an element ofthe device in and of itself. For example, a ridge may be formed on aportion of the device described herein, in a non-limiting embodiment,wherein he ridge is a protrusion. A protrusion may be formed as a ringfeature, wherein it extends around a portion of or the entirecircumference of the device, on an inner or outer surface of the device,in a non-limiting example.

The term “near” as used herein includes, but is not limited to the terms“at”, “adjacent to,” which describes an element in proximity to anotherelement, in one example. The term “near” may include, in a non-limitingembodiment, a distance of less than 8 inches. In another non-limitingembodiment, the term “near” may include a distance of between 1-2inches. In a further non-limiting embodiment, the term near may includea distance of between 1-5 centimeters. In still a further embodiment,the term “near” may include no distance between the elements discussed,i.e., includes the term “at”.

The inventors herein have identified that providing a resettableinjection training device that closely resembles a needle-containing,injectable medicament delivery device would be particularly beneficialfor easing a patient's fears and increasing familiarity and comfort of apatient with the device. Furthermore, the inventors have developed aresetting component used to reset the resettable injection trainingdevice to allow for subsequent uses during training. In one embodiment,the resetting component does not detract from the general shape and formfactor of the injection training device.

Turning to the drawings, FIG. 1 includes a cross sectional view of aresettable injection training device embodiment 100 prior to actuation.The resettable injection training device embodiment 100 includes a body10 comprising an inner body 14 and an outer body 12. The body 10 mayinclude channel 13 extending between a proximal end 10 b and a distalend 10 a of the body 10. The device embodiment 100 may include aninjection simulation member 26 extending from a distal end 10 a of thebody. The injection simulation member 26 may include a distal end havinga blunted or ball-end shape, or other such configuration as describedherein, or as known to one skilled in the art, in non limitingembodiments. In some non-limiting embodiments, the injection simulationmember may be formed of a monofilament material or other material knownto provide similar strength and flexure. In other non-limitingembodiments, the injection simulation member 26 may include atelescoping component, configured to extend the injection simulationmember 26 and to retract the injection simulation member 26. In stillfurther embodiments, the injection simulation member 26 may be coupledto, or may work in conjunction with an injection simulation membermechanism to extend or retract the injection simulation member relativeto the device. During use of the device, the injection simulation member26 can be pressed against a target surface of a user before actuation ofthe device. A cover 30, as shown over the injection simulation member 26in FIG. 1, may be removably engageable over the injection simulationmember 26, and can be removed prior to use of the device embodiment 100(as shown in FIG. 2).

At least a portion of a plunger 18 may be disposed within the inner body14, and the plunger 18 may be slidably engaged with the inner body 14,in one embodiment. The plunger 18 may be associated with a stopper 19 atits distal end, in a non-limiting embodiment. The device 100 can bemanually actuated by exerting a pressure on the plunger 18 to move theplunger 18 in a first direction relative to the body 10, toward thedistal end 10 a of the body until the distal plunger portion (or thestopper, in some embodiments) reaches the distal end 10 a of the body ascan be seen in FIG. 2. The body 10 may include a projection 21 on itsouter surface, which may include one more tab-like components projectingoutward from the device 100. In another embodiment, the projection 21may be formed as a radial projection extending outward from the body 10.The projection(s) 21 may be used by a user to apply a counter pressureto the pressure being applied to the plunger 18 to move the plunger 18relative to the device 100. The body 10 may further include a firstprotrusion 16 on an inner surface thereof, in a non-limiting example.The device 100 may further include a retractable shield 20 that retractsand extends relative to the body 10, and a biasing member 24 associatedtherewith (shown in a biased position in FIG. 1). The cover 30 is shownas removed from the device 100 in FIG. 2, while the shield 20 remainsretracted in the device 100. The retractable shield 20 may include aproximal end 20 b and a distal end 20 a, and a second protrusion 22 onan outer surface thereof. In an embodiment, when the shield 20 is in aretracted position as shown in FIGS. 1 and 2, the at least one secondprotrusion 22 may abut the at least one first protrusion 16. Theinteraction between the first and second protrusions 16, 22 maintainsthe shield 20 in a retracted position, in one non-limiting embodiment. Afirst threshold force on the plunger 18 may cause the at least onesecond protrusion 22 to traverse the at least one first protrusion 16 toextend the shield 20 as shown in FIG. 3. As illustrated in the crosssectional view of FIG. 3, a third protrusion 28 may abut the firstprotrusion 16 when the shield is in an extended position to hold theproximal end 20 b of the shield in the body 10 of the device 100.

The biasing member 24 includes a first end 24 b and a second end 24 a.The first end 24 b may abut a proximal end 10 b of the body, and thesecond end 24 a may abut the shield 20. Extension of the biasing member24 as shown in FIG. 3 may extend the shield 20, and retraction of thebiasing member 24 may retract the shield 20. The biasing member 24 maybe configured to apply a biasing force to the shield 20 that is lessthan the first threshold force. When the shield is in an extendedposition, a second threshold force applied to a distal end of the shield20 a retracts the shield 20, wherein the second threshold forcecomprises a force of (x) Newtons. The resettable injection trainingdevice embodiment 100 may optionally lack (i) a needle, (ii) injectionsimulating component 26, or (iii) a medicament, in non-limitingembodiments. In one non-limiting embodiment, the second threshold forcemay include a force of less than 100 N (Newtons). In another embodiment,the second threshold force may include a force between 5 N and 40 N.

Following extension of the retractable shield, a resetting component 32,shown in FIG. 4, may be used to reset the device embodiment 100 in onenon-limiting embodiment. The resetting component 32 may include a firstend 32 b and second end 32 a. The second end 32 a may be providedagainst a support surface, and the first end 32 b may be configured toreceive the retractable shield 20 of the device 100. In somenon-limiting embodiments, the resetting component 32 may include achannel 34 disposed between the first and second ends 32 a, 32 b,configured to receive the injection simulation member 26 duringresetting of the device 100. In order to reset the device 100, in oneembodiment, the distal end of the shield 20 a may be abutted against aportion of the resetting component 32. In one non-limiting example, theresetting component 32 may include one or more protrusions 36 extendinginwardly toward the channel 34 of the resetting component 32, so as toserve as one or more shoulder portions, for example, to abut the shield20 during resetting of the device 100. Abutting the distal end of theshield 20 a against the protrusion(s) 36 of the resetting component 32,and applying a pressure toward the resetting component 32 until thesecond protrusion 22 traverses the first protrusion 16, retracts theshield 20 into the device 100, to return the device to the positionshown in FIG. 2, prior to a subsequent use of the device 100. Followingresetting of the device 100, the injection simulation member 26 may beexposed, and the cover 30 may be placed over the injection simulationmember 26, as shown in FIG. 1 until a subsequent use of the device 100.

The resetting component 32 may include a form factor similar to a capfor the device 100, and may appear to be an extension of the device 100.The resetting component 32 need not be a bulky, difficult to maneuverdevice, but instead may include a streamlined form factor as shown, forexample, in the Figures herein.

In a non-limiting embodiment, in some instances the plunger 18 may needto be manually reset to its pre-use position (as shown in FIG. 1) bypulling on the plunger so that a greater portion of the plunger 18extends from the proximal end of the body 10 b of the device 100 tofully reset the device 100 prior to a subsequent use thereof. In othernon-limiting embodiments, the plunger 18 may be reset to its pre-useposition by mechanisms known to those skilled in the art, which include,but are not limited to biasing components and motors, among othermethods.

FIG. 5A includes a perspective view and FIG. 5B shows an end view of oneembodiment of the resettable injection training device showing a distalend 10 a of the device having a flexure component 40 to allow expansionof the diameter of the distal end 10 a to allow the a least one secondprotrusion 22 (not shown in FIG. 5A) to traverse the at least one firstprotrusion 16 (not shown in FIG. 5A) to extend the shield 20 (not shownin FIG. 5A). The embodiment of the flexure component 40 of the distalend as shown in FIG. 5A shows a number of openings 42 in the distal end10 a allowing the diameter of the distal end 10 a to increase as theshield passes through the diameter 10 a. These openings 42 may alsoallow the flexure component diameter to return to its original size oncethe second protrusion 22 traverses the first protrusion 16. In another,non-limiting embodiment, the flexure component 40 may include a materialthat may flex, stretch, or expand in response to pressure as the shield20 traverses the flexure component 40. The flexure component 40 mayprovide a resistance similar to the resistance that is met duringextension of the shield in a drug delivery device.

FIGS. 6A-B include cross-sectional views of an embodiment 200 of theresettable injection training device including a shield 20 having atleast one third protrusion 28 configured to associate with the at leastone first protrusion 16 when the shield 20 is in an extended position tolock the shield 20 in the extended position as shown in FIG. 6A. In oneembodiment, the interaction between the at least one first protrusion 16and the at least one third protrusion 28 may prevent the shield 20 fromretracting as shown in FIG. 6A. In one particular embodiment, the atleast one first protrusion 16 may include one or more tabs in the bodyof the device, wherein the one or more tabs may extend into the channelof the device to interact with the protrusion(s) 22, 28 on the shield asthe at least one second and/or third protrusions 22, 28 on the shield 20bypass the at least one first protrusion 16 on the body. In onenon-limiting embodiment, the at least one first protrusion 16 mayinclude a shape such that the at least one second and/or thirdprotrusion 22, 28 on the shield 20 can bypass the at least one firstprotrusion 16 when the shield 20 is moving toward the distal end of thedevice (when the shield is being extended); however the shape of the atleast one first protrusion 16 may prevent the shield from beingretracted (i.e., lock the shield in an extended position) by preventingmovement of the second and/or third protrusions 22, 28 past the firstprotrusions 16 on the body. This locking feature may be overcome by anunlocking component 70 of the device.

In an embodiment, the unlocking component 70 may be required to releasethe at least one first protrusion 16 from the at least one thirdprotrusion 28, for example, to allow retraction of the shield 20 toreset the device. In the non-limiting embodiment shown in FIGS. 6A-C,the unlocking component 70 may include a feature on or part of the bodyof the device that is activated to unlock and release the shield 20 sothe shield 20 can retract into the device. For example, as indicated bythe arrows in FIG. 6A, the unlocking component 70 in FIG. 6A can beactivated by exerting a pressure on the portion of the device designatedby the arrows. In other non limiting embodiments, the unlockingcomponent may be activated by rotating a portion of the device, orreleasing a pin or other mechanism known to those skilled in the art torelease the shield from its locked, extended position. Once a pressureis exerted on the unlocking component 70, as shown in FIG. 6B, the atleast one first protrusion 16 is released from the at least one thirdprotrusion 28, such that the shield 20 can be retracted into the device,either by way of a spring, or by manually exerting a force on the end ofthe shield 20 to retract the shield 20 as shown in FIG. 6C.

In another non-limiting alternative embodiment 300 of the resettableinjection training device provided in the cross sectional view of FIG.7, at least one fourth protrusion 29 may be included on the body tointeract with the at least one third protrusion 28 of the shield toprovide this locking feature and prevent retraction of the shield unlessthe at least one fourth protrusion 29 is released (i.e., unlocked via anunlocking component, for example). The unlocking component may include aportion of the body of the device which is compressed (as shown in FIGS.6A-C) to release the at least one fourth protrusion 29 to allow the atleast one third protrusion 28 to traverse the at least one fourthprotrusion 29 automatically, or by application of a force on the distalend of the shield 20 to retract the shield 20. The unlocking componentmay include a mechanical feature or a mechanical mechanism associatedwith the body or the shield to release the at least one fourthprotrusion 29 to retract the shield 20. In this embodiment, anadditional resetting tool may not be required to reset the shield to aretracted position.

In an alternative, non-limiting embodiment shown in FIG. 8, a resettableinjection training device 400 may be provided wherein at least one firstprotrusion 16 is provided on an inner surface of the outer body 12 neara proximal end of the outer body 12, and a retractable shield 20,slidably retractable and extendable relative to the body 12 may includea second protrusion 22 near a proximal end thereof. The secondprotrusion 22 may interact with the first protrusion 16 near theproximal end to maintain the shield 20 in a retracted position until afirst threshold force is placed on a plunger 18 to force the shield 20into an extended position such that the second protrusion 22 traversesthe first protrusion 16 on the inner surface of the outer body 12. In afurther embodiment, an additional protrusion, a fifth protrusion 17, maybe provided near a distal end of the inner surface of the outer body 12,as shown in FIG. 8. Fifth protrusion 17 may abut the second protrusion22 when the shield 20 is in an extended position to retain the proximalend of the shield 20 in the device. In the non-limiting embodiment shownin FIG. 8, the shield 20 may only have the at least one secondprotrusion 22 on its outer surface near the proximal end of the shield22, and no protrusions near the distal end of the shield 20.

A biasing member may be included as described in other embodimentsherein. In this non-limiting embodiment, retraction of the shield 20 mayinclude exerting a second threshold force required for the secondprotrusion 22 to traverse the first protrusion 16 near the proximal endof the inner surface of the body 12 to secure the shield 20 within thedevice for a subsequent use. The second threshold force may include (x)N (Newtons). The resettable injection training device may optionallylack (i) a needle, (ii) injection simulating component, or (iii) amedicament. In one further embodiment, (x) Newtons may include a forceless than 100 N.

In a further, non-limiting embodiment, a method is provided, the methodcomprising actuating an injection training device having a body, thebody comprising an inner body and an outer body, wherein the bodycomprises a first protrusion on an inner surface thereof. The deviceincludes a plunger disposed there within, and a retractable shield beingslidably movable relative to the device, the shield having a proximalend, a distal end and a second protrusion on an outer surface thereof,wherein in a retracted position, the second protrusion abuts the firstprotrusion, wherein actuation includes moving the plunger in a firstdirection relative to the body by exerting a first threshold force onthe plunger such that the second protrusion traverses the firstprotrusion, to extend the shield, and applying a second threshold forceon the distal end of the shield to retract the shield. The secondthreshold force may be applied to distal end of the shield until thesecond protrusion traverses the first protrusion such that the shield isretracted into the device.

While a number of embodiments of the present invention have been shownand described herein in the present context, such embodiments areprovided by way of example only, and not of limitation. Numerousvariations, changes and substitutions will occur to those of skill inthe art without materially departing from the invention herein. Forexample, the present invention need not be limited to best modedisclosed herein, since other applications can equally benefit from theteachings of the present invention. Also, in the claims,means-plus-function and step-plus-function clauses are intended to coverthe structures and acts, respectively, described herein as performingthe recited function and not only structural equivalents or actequivalents, but also equivalent structures or equivalent acts,respectively. Accordingly, all such modifications are intended to beincluded within the scope of this invention as defined in the followingclaims, in accordance with relevant law as to their interpretation.

While one or more embodiments of the present invention have been shownand described herein, such embodiments are provided by way of exampleonly. Variations, changes and substitutions may be made withoutdeparting from the invention herein. Accordingly, it is intended thatthe invention be limited only by the spirit and scope of the appendedclaims. The teachings of all references cited herein are incorporated intheir entirety to the extent not inconsistent with the teachings herein.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art of molecular biology. Although methods and materials similar orequivalent to those described herein can be used in the practice ortesting of the present invention, suitable methods and materials aredescribed herein. All publications, patent applications, patents, andother references mentioned herein are incorporated by reference in theirentirety. In case of conflict, the present specification, includingdefinitions, will control. In addition, the materials, methods, andexamples are illustrative only and are not intended to be limiting.

What is claimed is:
 1. A resettable injection training device,comprising: a body comprising an inner body and an outer body, said bodycomprising a proximal end and a distal end, and a chamber defined withinthe body, the outer body having at least one first protrusion on aninner surface thereof; a plunger slidable within the inner body; aretractable shield comprising a proximal end and a distal end, and beingretractable and extendable relative to the body, the shield comprisingat least one second protrusion on an outer surface thereof, wherein whenthe shield is in a retracted position, the at least one secondprotrusion abuts the at least one first protrusion, and wherein a firstthreshold force on the plunger causes the at least one second protrusionto traverse the at least one first protrusion to extend the shield; anda biasing member comprising a first end and a second end, the first endabutting a proximal end of the body, and the second end abutting theshield, wherein extension of the biasing member extends the shield, andretraction of the shield biases the biasing member, wherein the biasingmember is configured to apply a biasing force to the shield less thanthe first threshold force, and wherein when the shield is in an extendedposition, a second threshold force applied to the distal end of theshield retracts the shield, wherein the second threshold force comprisesa force of (x) N (Newtons); and wherein the resettable injectiontraining device comprises at least one of: (i) a needle, (ii) injectionsimulating component, or (iii) a medicament, wherein (x) comprises aforce that is greater than the biasing force.
 2. The resettableinjection training device of claim 1, wherein (x) comprises a force lessthan 100 N.
 3. The resettable injection training device of claim 1,further comprising at least one third protrusion on the shield proximalto the at least one second protrusion, wherein the at least one thirdprotrusion abuts the at least one first protrusion when the shield isextended.
 4. The resettable injection training device of claim 1,further comprising one or more tab portions in the body, each tabportion comprising at least one fourth protrusion extending into thechamber, wherein the at least one fourth protrusion component isconfigured to allow traversal of the at least one second protrusionrelative to the at least one fourth protrusion component uponapplication of a second threshold force to retract the shield.
 5. Theresettable injection training device of claim 1, wherein the at leastone first protrusion is disposed near a distal end of the body, and theat least one second protrusion is adjacent to a distal end of theshield.
 6. The resettable injection training device of claim 5, whereinthe distal end of the body comprises a flexure component to allowexpansion of a diameter of the distal end as the a least one secondprotrusion traverses the at least one first protrusion to extend theshield.
 7. The resettable injection training device of claim 1, whereinthe at least one first protrusion is disposed near a proximal end of thebody, and the at least one second protrusion is adjacent to a proximalend of the shield.
 8. The resettable injection training device of claim7, further comprising a fifth protrusion disposed near a distal end ofthe body, wherein said fifth protrusion abuts the at least one secondprotrusion when the shield is in an extended position.
 9. The resettableinjection training device of claim 1, wherein the device contains nomedicament.
 10. The resettable injection training device of claim 1,further comprising an injection simulation member disposed at a distalend of the device.
 11. The resettable injection training device of claim10, further comprising a cover removably securable over the injectionsimulation member.
 12. A method comprising: actuating an injectiontraining device having a body, the body comprising an inner body and anouter body, wherein the body comprises a first protrusion on an innersurface thereof, the device including a plunger disposed there within,and a retractable shield being slidably movable relative to the device,the shield having a proximal end, a distal end and a second protrusionon an outer surface thereof, wherein in a retracted position, the secondprotrusion abuts the first protrusion, wherein actuation comprisesmoving the plunger in a first direction relative to the body such thatthe second protrusion traverses the first protrusion, and the shield isextended; and applying a force on the distal end of the shield until thesecond protrusion traverses the first protrusion such that the shield isretracted.
 13. A resettable injection training device, comprising: abody comprising an inner body and an outer body, the body having aproximal end and a distal end, and a chamber defined within the body,the outer body having at least one first protrusion on an inner surfacethereof; a plunger slidable within the body; a retractable shieldcomprising a proximal end and a distal end, and being retractable andextendable relative to the body, the shield comprising at least onesecond protrusion on an outer surface thereof, wherein when the shieldis in a retracted position the at least one second protrusion abuts theat least one first protrusion, and wherein a first threshold force onthe plunger causes the at least one second protrusion to traverse the atleast one first protrusion to extend the shield, the shield comprisingat least one third protrusion proximal to the at least one secondprotrusion, wherein the at least one third protrusion abuts the at leastone first protrusion when the shield is extended; a biasing membercomprising a first end and a second end, the first end abutting aproximal end of the body, and the second end abutting the proximal endof the shield, wherein extension of the biasing member extends theshield, and retraction of the shield biases the biasing member, whereinthe biasing member is configured to apply a biasing force to the shieldless than the first threshold force, and wherein when the shield is inan extended position, a second threshold force applied to the distal endof the shield retracts the shield, wherein the second threshold forcecomprises a force of (x) N that is greater than the biasing force; andone or more tab portions in the body, each tab portion comprising atleast one fourth protrusion extending into the chamber, wherein the atleast one fourth protrusion comprises a locking surface configured toabut the at least one third protrusion to lock the shield in an extendedposition; and an unlocking component in contact with the body, whereincompression of the unlocking component releases the at least one fourthprotrusion from the at least one third protrusion, allowing movement ofthe at least one third protrusion relative to the at least one fourthprotrusion to retract the shield.
 14. The resettable injection trainingdevice of claim 13, wherein (x) comprises a force of less than 100 N.15. The resettable injection training device of claim 13, furthercomprising at least one third protrusion on the shield proximal to theat least one second protrusion, wherein the at least one thirdprotrusion abuts the at least one first protrusion when the shield isextended.
 16. The resettable injection training device of claim 13,further comprising one or more tab portions in the body, each tabportion comprising at least one fourth protrusion extending into thechamber, wherein the at least fourth protrusion component is configuredto allow traversal of the at least one second protrusion relative to theat least one fourth protrusion component upon application of a secondthreshold force to retract the shield.
 17. The resettable injectiontraining device of claim 13, wherein the at least one first protrusionis disposed near a distal end of the body, and the at least one secondprotrusion is adjacent to a distal end of the shield.
 18. The resettableinjection training device of claim 17, wherein the distal end of thebody comprises a flexure component to allow expansion of a diameter ofthe distal end as the a least one second protrusion traverses the atleast one first protrusion to extend the shield.
 19. The resettableinjection training device of claim 13, wherein the at least one firstprotrusion is disposed near a proximal end of the body, and the at leastone second protrusion is adjacent to a proximal end of the shield. 20.The resettable injection training device of claim 19, further comprisinga fifth protrusion disposed near a distal end of the body, wherein saidfifth protrusion abuts the at least one second protrusion when theshield is in an extended position.
 21. The resettable injection trainingdevice of claim 13, wherein the device contains no medicament.
 22. Theresettable injection training device of claim 13, further comprising aninjection simulation member disposed at a distal end of the device. 23.The resettable injection training device of claim 22, further comprisinga cover removably securable over the injection simulation member.